- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434988
Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy
June 22, 2022 updated by: Waleed Ghareeb, Suez Canal University
Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains.
The goal of the present study is to investigate if there is a difference between OA and LA in obese patients.
In the present study, Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included.
The study participants were assigned to two groups, after their approval: LA and OA.
The investigators hypothesized that evaluating the Outcome and Quality of life of laparoscopic appendectomy for the obese patients would be a potential step for standardization of the laparoscopic approach for obese patients who are arranged for appendectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains.
The investigators' goal is to investigate if there is a difference between OA and LA in obese patients.
Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included.
The study participants were assigned to two groups, LA and OA.
This study aimed to compare LA and OA regarding intraoperative complications, length of hospital stays, post-operative pain, and rate of postoperative complications.
Meanwhile, using the SF-36 scoring questionnaire, the quality of life was compared between both groups.
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ismailia, Egypt
- Suez Canal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
obese patients (body mass index >30kg/m2) who were diagnosed with acute appendicitis according to ALVARDO score at the department of surgery at Suez Canal university hospitals
Description
Inclusion Criteria:
- Patients aged between 18-40 years, with BMI ≥ 30 kg/m2 and diagnosed as acute appendicitis according to Alvarado score i.e., history of right lower quadrant pain or peri-umbilical pain shifting to the right lower quadrant with nausea and/or vomiting, fever of more than 38ºC, right lower quadrant guarding, and tenderness on physical examination and/or leukocytosis above 10,000 cells per ml were included.
Exclusion Criteria:
- The investigators excluded patients with a bleeding tendency., previous lower abdominal surgery, abdominal tuberculosis, mass formation either clinically or by ultrasound, end-stage renal disease (ESRD) patients, and patients who refused to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Laparoscopic appendectomy
The laparoscopic appendectomy group is the group that includes patients who underwent appendectomy using the laparoscopic approach
|
Open or Laparoscopic appendectomy procedure is typically performed under general anaesthesia.
in the laparoscopic approach, the main principle is the triangulation of instrument ports to visualize and expose the appendix clearly.
The first trocar (10 mm) for the optical device is introduced peri-umbilically, followed by two 5 mm trocars, one in the right lower quadrant just above the pubis (to grasp the appendix) and the other in the left iliac fossa (for the (right-handed) surgeon's right hand), assuming the appendix is in its normal anatomic position.
The locations of the 5 mm trocars can be changed based on the anatomic position of the appendix as determined before to surgery (for example a subhepatic appendix could lead to placing the trocars as for cholecystectomy)
|
Open appendectomy
The open appendectomy group is the group that includes patients who underwent appendectomy using laparoscopic approach
|
Open or Laparoscopic appendectomy procedure is typically performed under general anaesthesia.
in the laparoscopic approach, the main principle is the triangulation of instrument ports to visualize and expose the appendix clearly.
The first trocar (10 mm) for the optical device is introduced peri-umbilically, followed by two 5 mm trocars, one in the right lower quadrant just above the pubis (to grasp the appendix) and the other in the left iliac fossa (for the (right-handed) surgeon's right hand), assuming the appendix is in its normal anatomic position.
The locations of the 5 mm trocars can be changed based on the anatomic position of the appendix as determined before to surgery (for example a subhepatic appendix could lead to placing the trocars as for cholecystectomy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The grade of The Clavien-Dindo for postoperative complications
Time Frame: 30 days
|
compare the laparoscopic appendectomy vs. Open appendectomy in terms of intraoperative and postoperative complications during the 30 days postoperative (The Clavien-Dindo )
|
30 days
|
The score for quality of life
Time Frame: 30 days
|
the postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire.
The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items).
The higher scores mean better quality of life..
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed H Hussein, MD, PhD, Suez canal University, Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
August 26, 2021
Study Registration Dates
First Submitted
June 17, 2022
First Submitted That Met QC Criteria
June 22, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 22, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4245/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
All data are available with the principal investigator on reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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